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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study (ip application)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
Internal BASF method was used
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): pentanol-1 (n-pentanol)
- Physical state: liquid
- Analytical purity: ca. 99%

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kisslegg mouse
- Weight at study initiation: mean 29.8 g (male), 25.6 g (female)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
- Concentration of vehicle (aqueous suspension): 0.5%
- Concentration of test substance in vehicle: 2, 4, 16%
- Applied volume: 10 or 20 ml
Doses:
0.2, 0.4, 0.8, 1.6 ml/kg bw (ca. 163, 326, 652, 1304 mg/kg bw assuming a density of 0.815 g/ml)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily recording of signs and symptoms from the day of administration till the end of the observation period. Daily check (twice) for moribund and dead animals (once during the weekend).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 326 mg/kg bw
Based on:
test mat.
Mortality:
0.2 ml/kg bw: no mortalities
0.4 ml/kg bw: 1/5 male within 24 h; 2/5 males within 7 days; 3/5 males within 14 days; 1/5 female within 7 days
0.8 ml/kg bw: 2/5 males within 24 h; 4/5 males within 7 days; 3/5 females within 48 h; 5/5 females within 7 days
1.6 ml/kg bw: 2/5 males within 1 h; 5/5 males within 7 days; 5/5 females within 1 h
Clinical signs:
0.2 ml/kg bw: directly after treatment: tachypnea, staggering and abdominal posture; after few minutes: tachypnea and staggering; from ca. 5 hours onwards: squatting posture and tachypnea; nothing abnormal was detectable in surviving animals from day 6 after treatment
0.4 ml/kg bw: directly after treatment: tachypnea, staggering and abdominal posture; after few minutes: atony, intermittent tremor and scampering gait; from ca. 5 hours onwards: squatting posture and tachypnea; nothing abnormal was detectable in surviving animals from day 13 after treatment
0.8 ml/kg bw: First day after treatment: tachypnea, staggering, atony, apathy and dyspnea. Narcosis and squatting posture partly observed; during the following days: squatting; nothing abnormal was detectable in surviving animals from day 12 after treatment
1.6 ml/kg bw: directly after treatment: tachypnea, staggering and abdominal posture; after few minutes: dyspnea and narcosis; after ca. 5 hours: dyspnea; after 2 days: intermittent tremor the 2 last animals died at day 6
Body weight:
no abnormality reported
Gross pathology:
- Survivors: nothing abnormal detected (with the exception of slightly liver size increase in the 6 animals of the 0.4 ml/kg group)
- Dead animals: loam grey staining (in 7 animals of the 1.6 ml/kg and 6 of the 0.8 ml/kg group); liver congestion hyperemia (in 3 animals of the 1.6 ml/kg and 1 of the 0.4 ml/kg group); atonic gut (in 1animal of the 0.4 ml/kg group); intra-abdominal agglutination (in 1 animal of the 0.4 mg/kg group); venous hyperemia (in 3 of the 0.8 ml/kg group); intra-intestinal diarrheal content (in 1 animal of the 0.4 ml/kg and 3 of the 0.8 ml/kg group).

Any other information on results incl. tables

Original value: LD50 = ca. 0.4 mL/kg bw

Applicant's summary and conclusion